Diabetes is a difficult condition to live with, but when it leads to complications like diabetic foot ulcers (DFU), there can be even more pain and suffering. A diabetic foot ulcer is one of the most prevalent complications that develop when someone has diabetes. The DFU can lead to severe effects, including amputation in some cases–a major loss for patients who have this condition.
There are approximately 1 million amputations related to DFUs each year, and that number is likely underestimated. These complications lead to serious quality of life issues for diabetic patients. Consequently, improving therapies for DFUs is crucial in order to control this epidemic and its consequences. Stem cell therapy is a promising treatment for DFUs.
Mesenchymal stem cells (MSCs) activate endogenous repair mechanisms by releasing soluble factors that stimulate angiogenesis, re-epithelialization, collagen deposition, and wound contraction. Additionally, MSCs seem to be able to modulate the inflammatory response by inhibiting the recruitment and/or the activation of pro-inflammatory cells.
Different studies indicated that local injections of MSCs are safe and feasible in DFUs even if big controlled clinical trials are still needed to confirm their efficacy in clinical practice. Therefore, MSCs represent a potential tool for the treatment of DFU with a high therapeutic index that could be widely translated into clinical practice.
A study, Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF), looked into the potential of stem cell therapy for treating DFUs.
Results of the Study
Patients may require minor foot amputations, but healing those amputations can be difficult. The primary goal of the study was to evaluate the healing rate and timing of patients who were treated with stem cells after receiving a minor amputation. The researchers were interested in determining if stem cells could improve diabetic patient minor amputation outcomes.
The study’s secondary outcome was to determine the safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain of the treatment. One hundred fourteen patients were recruited for the study, which took place in Italy from April 2015 to March 2017. Patients were split evenly into two groups.
In both groups, patients underwent minor amputations. In the stem cell group, the patients received injections of micro-fragmented adipose tissue radially into the bed of the amputation. The control group received injections of povidone-iodine solution in the same area. The researchers followed up with patients every month after the surgery for six months.
The results of the study were extremely promising for patients with DFUs. The researchers found that this treatment was safe for patients who suffered from minor amputations related to DFUs. The stem cell therapy group did not experience any treatment-related adverse events. There were also no relapses in either group.
Six months after receiving the treatment, 80% of the stem cell therapy group recovered from their diabetic foot ulcers, while only 20% failed to heal. This improvement was a massive difference compared to the control group. In the control group, only 46% of patients recovered from their minor amputations. There was no pain difference between the two groups.
Diabetes is a major health problem worldwide, and diabetic foot ulcers are a common complication. Although several treatment options are available, healing can be slow and difficult to achieve. The results showed that local injection was safe and effective and improved healing rates compared to control patients. Further high-quality studies are warranted to confirm these preliminary encouraging results.
